Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 3
- 主要终点
- CTC Enumeration
研究概览
简要总结
The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspected lung cancer
- •Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
排除标准
- •Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
- •Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
- •Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
- •Inability to provide informed consent.
- •Hgb less than 8.
结局指标
主要结局
CTC Enumeration
时间窗: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol. These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance. Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis. Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.
次要结局
- Lung Cancer Subtyping(3 months from baseline, an average of 2 weeks post patient tissue biopsy)
- Nodal Staging(3 months from baseline, an average of 2 weeks post patient tissue biopsy)
- Establish the Prognostic Value by measuring CTC count over time.(Baseline, 3 months, 24 months and 66 months)